System and method for protecting oral tissues from smokeless tobacco

ABSTRACT

The present invention involves a system and method for a user of smokeless tobacco to reduce the deleterious effects to oral tissues from the chemicals generated from using smokeless tobacco. A protective shield encloses a quantity of tobacco while resting in a mouth of a user, generally between the cheek and gum surfaces. The protective shield may be impermeable, sanitary, and disposable or biodegradable. It may assist in reducing leukoplakia and other oral diseases related to the use of smokeless tobacco. It attempts to allow the normal use of smokeless tobacco without interfering with speech, drinking, and other activities while providing some protection from the chemicals. The present invention involves a system and includes a container for holding the shields, having an opening for removing the shields for convenience and to encourage use, typically in the vicinity to a quantity of smokeless tobacco for easy access. It can be integrated into a lid of a smokeless tobacco container or other locations as well as sold as separate packets.

This Appln is a 371 of PCT/US96/00016 filed Oct. 10, 1996 and also claimthe benefit of U.S. Provisional Application No. 60/005,200 filed Oct.11, 1995.

TECHNICAL FIELD

This invention relates to smokeless tobacco protective devices andmethods. Specifically, it seeks to address the problems of leukoplakiaand other oral diseases related to the use of smokeless tobacco.

BACKGROUND ART

People have used smokeless tobacco for decades and even centuries.Today, an estimated 20 million Americans use smokeless tobacco products.Many believe that they avoid the dangers of smoking tobacco. Theybelieve that by not inhaling the tar of cigarettes, they avoid the lungcancer so prevalent among smokers. But smokeless tobacco has its ownproblems.

Smokeless tobacco irritates the gums, causes them to recede, andultimately may cause the teeth to loosen. It also irritates the insidelips, cheeks, and at times the throat. Additionally, smokeless tobaccocauses sores inside the cheeks. These sores are known as leukoplakia.These sores appear as white patches, typically between the cheeks andgums.

Additionally, smokeless tobacco is increasingly viewed as a primarycause of mouth cancer. The smokeless tobacco contains nitrosamine,cadmium, and other chemicals. Short term users may be four times aslikely to develop cancer as nonusers and long term users may be fiftytimes as likely to develop cancer as nonusers. The risks of tumors aregreatest at the place where the plug or dip of tobacco is held,typically between the cheek and gum.

Smokeless tobacco may also lead to addiction. It appears that directcontact of the tobacco with the mucous membrane combined with theextended time that the smokeless tobacco is held between the cheek andgum creates a localized concentrated level of nicotine which is absorbedthrough the mucous membranes. Smokeless tobacco contains high levels ofnicotine; some researchers have proposed that dipping with smokelesstobacco is more addictive than smoking tobacco, because higher levels ofnicotine are released into the bloodstream during use. Unfortunately,users suffer through the same pangs of withdrawal as smokers, withsymptoms that include irritability, anxiety, insomnia, and impairedconcentration. For some, to stop using smokeless tobacco is simply notperceived as worth the symptoms of withdrawal.

The typical focus to those seeking to avoid the above problems is to tryto stop the tobacco's use. Such efforts may emphasize quitting orsubstituting artificial products for the smokeless tobacco. Programsinclude a national ban on smokeless tobacco television advertising since1986 and warnings on the tobacco cans stating, "This product may causemouth cancer." Legislation and articles are aimed usually at stoppingdipping or otherwise using smokeless tobacco. Some programs suggestsubstituting the tobacco nicotine with nicotine gum. This practiceminimizes the direct chemical contact of smokeless tobacco. Anotheroption is a mint flavored snuff which is advertised as containing notobacco and no nicotine.

These advertisements, programs, and products provide a substitute. Theydo not address the problem of continuing to use tobacco while lesseningthe risk of using the tobacco. While abstinence may be commendable, itdoes not address lessening the discomfort and other effects for thosewho refuse or are unable to stop. Also, it does not provide thephysiological effects of nicotine from true tobacco. Therefore, someindividuals simply will continue to use tobacco.

U.S. Pat. No. 5,346,734 ("'734") attempts to address these problems. Itdiscloses a preformed, relatively thick (0.025" or 25 mills), perforatedlatex pouch with closed ends for use with smokeless tobacco. The pouchrequires cutting to conform to the depth of the user's mouth. However,the preformed pouch does not fit all mouths because mouths and bonestructures are different. That invention appears to be made to fitbetween the front lower gum and front lower lip only. However, most"dippers" only use the front part of the mouth when the sides are toosore from the direct contact of the tobacco fibers. So, the '734disclosure has limited application. The '734 device seems unsanitary.After the user finally cuts the shape to fit, he would seemingly want tocontinue to reuse it or relegate himself to cutting a new mouthpieceeach time he dips. The perforations can become clogged and lead tofurther unsanitary conditions on reuse. Additionally, in the field, suchas hiking, fishing, and so forth, there may be no place to rinse andclean the '734 apparatus. Also, it seems to disclose a perforated deviceonly. It also seems inconvenient to carry. The user in the field mustmake the apparatus stay in his mouth for the duration or find a suitableplace for storage, other than a bare pocket. It appears difficult andmessy to pack. The '734 requires either carrying a pair of scissors orhaving enough foresight to pre-form enough mouthpieces or to use thesame one repeatedly. These limiting options are especially burdensomewhen the typical user dips an average of 4-7 times daily, depending onhis activities. The '734 disclosure teaches away from biodegradableembodiments in that the intent appears to be that a user would purchasethe molded mouthpiece, trim it particularly for the user's mouth, thenreuse it to gain the benefit from the extra work of trimming. Such anarrangement appears not conducive to ready disposability andbiodegradability. It would also seem to interfere with speech anddrinking because of its formed structure and thickness. In summary, the'734 device does not appear to answer the needs of a typical smokelesstobacco user. A typical smokeless user will probably not use the '734device routinely, if at all. Thus, the problems of using smokelesstobacco are not effectively solved.

Even after decades of use and efforts by some, what remains then is thelack of a suitable device, method, or system for addressing the needs ofthose who use smokeless tobacco. A solution is needed that will protectoral tissues from the concentrated levels of chemicals which appear tobe a result of the direct contact of tobacco fibers. The solution shouldbe commercially feasible. This aspect involves the expense tomanufacture and purchase. It also involves: the compactness and abilityto be stored; flexibility to conform to variations between varioususers' mouths and within different locations of an user's mouth; minimalinterference with the normal routine of dipping so as to encourage useof the solution; minimal interference with normal occurrences throughoutthe day such as speaking and drinking; sanitary and clean to use; and ingeneral so natural and convenient that the user could routinely chose touse the solution with his regular dipping habits.

DISCLOSURE OF THE INVENTION

The present invention seeks to solve these problems. It involves ashield which helps act as a barrier or a restriction to reduce tobaccocontact with the sensitive inner cheek lining and gum sufaces whiledipping smokeless tobacco. It can be capable of folding, can be closedended, can be flexible for bending, or can be hinged. It can be creasedfor folding assistance.

The present invention also involves a method of placing smokelesstobacco in one's mouth as similar as possible to the customary mannerwith the additional step or steps of placing tobacco on or otherwise inthe proximity of a shield and inserting the combination of tobacco andshield into the mouth for comfortable protection. This offers analternative to the typical practice of relocating the unshielded diparound the mouth as sores develop which could damage other unprotectedareas as well. One goal is to provide a shield for cleaner use thatwould reduce loose or floating tobacco grains while using tobacco.Another goal is to provide a protection that is easy and convenient touse. Another goal is to promote a healthier use of smokeless tobacco.

The present invention also involves a system for holding the shields,having an opening for removing the shields for convenience and toencourage use. It can be integrated into a lid of a smokeless tobaccocan, into the bottom of the can or on the sides, placed in the interiorof the can with the tobacco, or affixed to the can by attachments,adhesives, or other fastening methods known to those in the art.

The present invention also involves a system to help decrease the risksof leukoplakia and other mouth diseases and may lessen the risks ofmouth cancer by having a shield for holding the smokeless tobacco in themouth and a container for the shields to provide portability andsanitation for convenience and encouragement in the use of the shields.

The object of the invention is also to provide a system and method forproviding an alternative to quitting using smokeless tobacco for thosewho decline to quit, while potentially reducing the risk of cheek andgum disease and generally reducing the discomfort and other effects tothe oral tissues from the chemicals generated from using smokelesstobacco.

The object of the invention also is to provide a system and method forusers of smokeless tobacco to potentially decrease the risks of cancer.

Another object of the invention is to provide a system and method forproviding a shield that may be comfortable and encourage use to yieldthe benefits of less risk of mouth diseases.

Another object of the invention is to provide a system for containing ashield to allow easy and convenient accessibility to the user ofsmokeless tobacco by being proximate to the smokeless tobacco, therebyencouraging such use.

Another object of the invention is to provide a system that isdisposable for sanitation and other reasons.

Another object of the invention is to provide a system for providing analternative to quitting using smokeless tobacco that includes a shieldor shields and a container for holding such shield or shields, therebyencouraging the use of the shield when dipping smokeless tobacco toobtain the benefits of the shield.

Another object of the invention is to provide a system for usingsmokeless tobacco that potentially lessens the risk of mouth diseasethat includes a self-contained pouch of a shield, a quantity of tobacco,and a means for opening the pouch to expose the quantity of tobacco tosaliva in the mouth.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 shows a shield and a dip of tobacco.

FIG. 1a shows a side view of the shield of FIG. 1.

FIG. 2 shows a cross section of a mouth having a cheek lining, gumtissues, teeth, a shield and a dip of tobacco in the shield.

FIG. 3 shows one of the many variations in shapes of the shield.

FIG. 4 shows a shield forming a pouch with ends.

FIG. 5 shows a shield with holes.

FIG. 6 shows one of the many variations in shape and spacing of theholes.

FIG. 7 shows a variation of the pouch, having a removable top section.

FIG. 8 shows another variation of the pouch, having a tear away stringto open the pouch.

FIG. 9 shows another variation of the pouch, having a perforated sectionto open the pouch.

FIG. 10 shows another variation of the pouch, having a dissolvablesection.

FIG. 11 shows a typical can of smokeless tobacco.

FIG. 12 shows a container and method of storing the shields foras-needed use.

FIG. 13 shows a can with a modified top, having a chamber for storingthe shields.

FIG. 14 shows a can with a modified top, having a removable tab foraccessing the shields.

FIG. 15 shows a shield packet for storing shields that can beincorporated into a container or made as a separate packet.

FIG. 16 shows a cross section of FIG. 15.

FIG. 17 shows a modified shield packet of FIG. 15, having a foldable topto protect the shields.

FIG. 18 shows a cross section of FIG. 17.

FIG. 18a shows another embodiment of the shield packet.

FIG. 18b shows another view of the embodiment of FIG. 18a.

FIG. 19 shows another container for storing the shields, having arotatable top and a bottom section with an opening that can be alignedwith the rotatable top for gaining access to the shields.

FIG. 20 shows a container of FIG. 19 with the top rotated in a closedposition, protecting the shields.

FIG. 21 shows another container with a rotatable top, pinned in anoffset position, so that when the top is rotated, the chamber for theshields is exposed.

FIG. 22 shows a container of FIG. 21 in an open position.

FIG. 1b shows a typical smokeless tobacco can.

FIG. 2a shows an open smokeless tobacco can, a lid, and the containedsmokeless tobacco.

FIG. 3a shows another view of the can and underside of the lid.

FIG. 4a shows several shields placed about and on the can.

FIG. 5a shows a shield held in place on one hand, using at least 2fingers on top and at least one finger below, as would be typical in theusage of the shield.

FIG. 6a shows a quantity of tobacco held between the fingers, in atypical position, generally known as a "dip" or "plug."

FIG. 7a shows the dip held between the fingers and placed in theproximity of the shield with a hand in a typical position similar toFIG. 6a.

FIG. 8a shows the shield folded slightly to partially enclose the dip toprepare for insertion in the mouth with a hand in a typical positionsimilar to FIG. 6a.

FIG. 8b shows one method of folding the shield to partially enclose thedip.

FIG. 9a shows the shield containing the tobacco being placed into amouth, typically between the side of a cheek and a gum.

FIG. 10a shows the a side view of dip after use with the shield, showingthe relatively intact tobacco contained in the shield.

FIG. 10b shows an end view of FIG. 10a.

FIG. 10c shows a top view of FIG. 10a.

FIG. 11a shows a chamber for the shield located in the lid of the can,having a flip-top lid for the shield to be extracted from the chamber.

FIG. 12a shows a shield as it is pulled from the shield chamber on thecan.

BEST MODE FOR CARRYING OUT THE INVENTION

As can be easily understood, the basic concept of the present inventionmay be embodied in a variety of ways. It involves the shields, themethod of using the shields, the container for holding the shields, anda system of protection relating to the shields. Various techniques,related devices and steps are inherent to utilization. They may simplybe the natural result of utilizing the devices as intended anddescribed. In addition, while some devices are disclosed, it would beunderstood that these not only accomplish certain methods but also canbe varied in a number of ways. Importantly, as to all of the foregoing,all of these facets should be understood to be encompassed by thispatent.

The advantages of the present invention are in direct contrast to the'734 disclosure. The present invention has several features that maylead to commercial viability. It seems inexpensive to manufacture. Itseems compact. Several shields may be stored in a can of tobacco forlater use or in separate packets about the size of a paper match packet.For example, a packet of approximately 20 shields could be sold as aseparate packet.

It may be flexible. It generally needs no cutting or trimming to fit theuser's mouth. It may fold or bend into place. The user can maintain hisusual routine of using smokeless tobacco with little interference, incontrast to molded fixtures or holders. The shield may occupy littlespace in the mouth and the user has little extra bulk in dippingtobacco. The typical thickness may be 0.5-6 mills (a mill equals 1/1000of an inch), and preferably the approximate thickness of a polyethylenesandwich bag which may be generally 0.75-1.25 mills (approximately 25times thinner than the '734 disclosure). This flexibility may assist theshield in bending to the various contours with minimal resistance to thetopography of the oral surfaces of a mouth. Minimal resistance could besuch that the shield could be relocated to any part of the mouth thatusers of smokeless tobacco are accustomed to placing the dip. Thisflexibility may assist a user in "upper dipping", a technique used byusers to place the tobacco in the upper half of the mouth, and stillretain the grains of tobacco in a more confined enclosure. Thisflexibility may also be beneficial in sizing the shield. Althoughdifferent sizes could be made, the shield appears so flexible thatconceivably one size could fit all; any extra material could bend withthe contours of the mouth tissues and surfaces and thus be intra-oral.This flexibility also is advantageous in that the shield is notconstrained to one location in the mouth; it can be used in numerouslocations in the mouth and thus be inter-oral. In a more general sense,the shield may be described as universally conforming to accomodatedifferent users and different positions. The shield appears to notinterfere with speech, drinking, or other normal occurrences that a usercould experience throughout the day. Generally, the shield is notvisible to others, and almost unnoticeable by the user, while in themouth.

The shield can be medicated, lubricated, or flavored to enhance its useand desirability with additives. Such additives could includemedications to assist in reducing the influence of smokeless tobacco onoral tissues. This medication could be a soothing additive such as aloeor could be any number of other medications. The medications or otheradditives may be time released.

The shield may even contain symbols or writing on it such as advertisingtrademarks, instructions, coupons, and so forth. The shield may alsohave a texture that may assist in using the shield or extracting it froma container or separating it from other adjacent shields. In thepreferred embodiment, the shield is considered sanitary; it is designedto be a one time use. Thus, cleaning, disinfecting or complicatedhygienic storage is not needed; use it and throw it away.

It may promote cleanliness in dipping. By placing the dip on the shield,prior to placing in the mouth, the dip is more contained and lessspillage results. Also, the tobacco fibers tend to migrate around themouth during use. The shield helps keep the fibers in a centrallocation. When removing the shield from the mouth, the large majority ofthe tobacco fibers are removed as a relatively intact unit with theshield, as shown in FIG. 10a.

The shield can be made of biodegradable material. The typical length oftime any specific dip is in the user's mouth is a few hours. Thus, thematerial can be made to last an appropriate length of time. This aspectenhances the disposability of the shield and other environmentalconcerns.

Thus, the present invention addresses the needs of those who usesmokeless tobacco in a heretofore unrecognized manner. It answers thoseneeds in a practical, commercially viable manner, while assisting inprotecting the oral tissues from direct contact of the tobacco fibers.

The purpose of the shield is to reduce or eliminate the direct contactof tobacco to the inner membranes or linings of the mouth, in particularthe cheek linings and gum tissues. It appears that the typical use ofsmokeless tobacco results in a concentrated area of direct contact ofthe tobacco fibers. This concentration may result in a level of chemicalcontact from the tobacco that is above some tolerance threshold for theinner linings of the mouth. The result is leukoplakia which has beenreported to be associated with a 3%-6% probability of mouth cancer.Pictorially, the chemical concentration might be represented as follows:##STR1## Level A represents some oral tolerance level of chemicalscontained in tobacco and B represents some higher concentration level ofchemicals from the tobacco fibers directly contacting the tissues of thecheeks and gums. As the concentration level increases above level A, itappears the cheek linings and gum tissues may react adversely. To newusers of smokeless tobacco, the oral tissues and linings sometimes stingor bleed. Even to veteran users, the cheek linings may become sore andwrinkled. This soreness seems especially prevalent in the crevassebetween the cheek and gum known as the buccal mucosa. To compensate forthis soreness, the user typically changes the location of where the dipis held in the mouth, and thus may promote further damage to other areasof the mouth with an unshielded dip.

With the inventor using the shield, the shield has produced astoundingresults. The soreness and wrinkles were reduced and the white sores(leukoplakia) faded or disappeared. It is believed that the shield actsto reduce the direct contact of tobacco and the lining of the skin isbetter able to tolerate the chemicals released from the smokelesstobacco. The level could be below some tolerance level as shown below.##STR2## Again, level A is some tolerance level as shown in Chart 1;levels C and D represent new levels where the dip of tobacco liquidcomes from the outer edges of the shield and contacts the lining of thecheek and gum tissues (but without the direct contact of the tobaccofibers); and E is some lower level beneath the shield where the contactof tobacco and the tobacco liquid is reduced. Thus, the level of adversechemicals appears to be reduced by the shield interposed between thetobacco and the tissues of the mouth and in particular the cheek andgum.

If the X-axis of Chart 2 is drawn to follow the periphery of the shieldwhile inserted in the mouth, the chemical concentration might resemblethat depicted in Chart 3 as follows: ##STR3## Again, level A is sometolerance level. Levels C' and D' may represent the levels at theperiphery of the shield's edge as the chemicals contact the tissues.Levels C' and D' appear to be lower than level B of Chart 1, because thetobacco fibers may minimally directly contact the tissues. The areabetween C' and D' appears to be more constant than Chart 2 because thelevel in Chart 3 represent the chemicals along the periphery of theshield.

Without this shield and with long exposure to the portion of smokelesstobacco placed between the gum and cheek, known as a "dip," the insidesurfaces of the cheek may become sore, wrinkled, and sensitive. Then,the user may switch sides to allow that section of the cheek to heal.Then, if the user's other cheek becomes sore and sensitive and if thefirst cheek is not healed, the user may move the dip between the lowerlip and gum forward of the teeth. Thus, the user generally moves the diparound the mouth to allow the respective cheek surfaces to heal.

The present invention lessens the need for this movement and helpsprotect the cheek and adjacent gum tissues. The concentrated point ofcontact of the tobacco fibers against the cheek and gum surfaces seemsto be reduced. Cheeks generally may feel better and cleaner.Additionally, because the shield works with any of the major brands, auser does not need to switch to an alternate brand or artificial source,nor alter his size of dip, and so forth, which the user may refuse todo. Thus, use of the shield is encouraged.

It is postulated that use of the shield may lessen the risk of cancerbecause the point contact of the tobacco fibers to the cheek and gumtissues is reduced or eliminated. It is believed that the highconcentration of tobacco in direct contact with the inner lining of thecheek and gum tissues encourages or causes the leukoplakia, cancer, orother diseases. When this contact is reduced or eliminated by the use ofthe shield, the deadening of the skin appears reduced and theleukoplakia seems reduced or eliminated. Thus, the shield might evenserve as a disease and cancer deterrent. The damaged area seems toregenerate the oral tissues with the use of a shield while stillallowing otherwise normal dipping practice.

FIG. 1 shows a basic shield (1) with a suitable size of the tobacco,known as a "plug" or "dip" (2), above the shield (1). The shield (1) iscapable of being flexible and thin, as shown in the side view of theshield in FIG. 1a. However, it should not be so thin and flexible thatit loses its structural integrity when handled and placed in a mouth (3)or while resting in the mouth (3), as shown in FIG. 2. Conversely, itshould not be not so thick that is uncomfortable in a user's mouth. Athickness that has been found to be useful is the thickness of a typicalpolyethylene sandwich bag, typically 0.75-1.25 mills, although generally0.5-6 mills could suffice and other variations could apply as long as agoal or object of the present invention could be accomplished.

FIG. 2 shows a cross section of a typical mouth (3), showing an innerlining of a cheek (4), teeth (5), and gum tissues (6). The shield (1)typically rests between the gum tissues (6) and the inner lining (4) andencloses or contains the dip (2) at least partially.

The size of the shield (1) should be of sufficient size to at leastpartially enclose the dip (2) except, perhaps, for the ends. Onepossibility of this dimension is approximately two inches in diameterwhich appears to be comfortable, allows easy placement of the dip (2),and enables easy insertion in the mouth (3). The size can be smaller orlarger depending on the size of the dip (2) and preference of the user.The lower limit of the shield (1) may be a size no smaller than thatnecessary to maintain the dip (2) substantially in the shield (1) whilein the mouth (3). One proper size may be the size that would fit in thediameter of a lid (20) of a tobacco container (19) of FIG. 12 and allowready removal of the shield (1).

The shape of the shield (1) can vary. It can be round as shown in FIG.1, circular, oblong, elliptical, square, rectangular, trapezoidal, orother shapes and configurations, as shown in FIG. 3, that would allowthe primary purposes of the invention, namely, the retention of the dip(2), the ease of placement of the dip (2) on the shield (1) and in themouth (3), and the reduction or elimination of direct contact of the dipwith the cheek inner lining (4) and gum tissues (6). The circular shapeappears to be somewhat self-aligning. The term "self-aligning" is meantto portray that one face of a shield may rapidly be aligned as it isfolded to another face of the shield, so that edges of the two faces aresubstantially aligned edge to edge. A circular shield, for instance, maybe folded in any 360° direction to align with an opposing face and socould be considered "rapid" as used herein. In contrast, for example, arectangular shield might be able to align the edges of the two opposingfaces in a folded condition in only two axis and would be "slower" as itwould take longer and more care to align the edges of the faces.

The shield (1) can be made of some sanitary plastic, paper, cloth, orother flexible material that reduces or eliminates the direct contact ofthe dip (2). It could be biodegradable for environmental considerations.The material could be a firm or even hard material that hinges or ismolded into a shape that would fit in the mouth (3). The material may beimpermeable, as would be understood to those with ordinary skill in theart regarding plastics including thin polyethylene, semi-permeable, orin some embodiments, permeable. In this context, "semi-impermeable"means that the material is less permeable than a screen or porous pouch(similar to a common tea bag) and can include small holes, pores, ormicro pores.

An alternative embodiment is shown in FIG. 4 and resembles a preformedpouch (1a). The preforming could be done at the time of manufacture oreven just prior to insertion into the user's mouth. The shield (1) mayhave a shield screen (7) on the end or ends (8) to retain the dip (2).The shield screen (7) can be a netting, screen, or other permeablematerial to allow the dip of tobacco liquid to flow into the mouth (3).Alternatively, the ends (8) could be of impermeable or semi-permeablematerial so that the shield forms an enclosed pouch with a pouch opening(9) at the top. It is envisioned that this arrangement could retain thedip (2) fibers better than the open-ended embodiment shown in FIG. 2.The opening (9) could be on different sides or even on the bottom aslong as the arrangement more fully enclosed the dip (2) than theopen-ended embodiment. The user could place the dip (2) into theembodiment and then insert it into the user's mouth (3).

A further embodiment is shown in FIG. 5. This embodiment envisions holes(10) in the shield (1) to allow the flavor of the tobacco to contact thecheek linings and other inner oral surfaces. Holes (10) can be ofvarying shapes including circular, elliptical, squares, or other shapesincluding random shapes and slits. The size of the holes (10) can varydepending on the purpose and intensity of the contact that is desired,from microscopic to one quarter inch in width or more. While thisembodiment is less preferred with respect to protection, it may offersome additional benefit in flavor or in allowing more nicotine or otherchemicals to contact the inner oral tissues at a higher localizedconcentration. Some users may be willing to compromise the protection ifthey feel the holes (10) would allow some limited contact of the dip (2)of tobacco and feel such contact would produce more of the sensationassociated with nicotine and other chemicals. Chart 4 would envisionthis approach to the level of chemicals contacting the linings of thecheek (4) and gum tissues (6). ##STR4## Level A is the tolerance levelas shown in Chart 1, F and G are the new higher levels where the dip (2)of tobacco liquid contacts the lining of the cheek (4) and gum tissues(6) but without the amount of direct contact of the fibers of the dip(2) (shown in Chart 1), and H is the level created by the holes in theshield. Thus, the level of adverse chemicals may still be reduced by theshield interposed between the tobacco and the tissues of the mouth, butthe level H is raised in comparison to level E of Chart 2.

The level of concentration surrounding level H could be varied dependingon the size, placement, and number of holes, which can be experimentallydetermined depending on desires of the user. By way of example andwithout limiting the possibilities, if the shield (1) were circular, theholes (10) could be spaced in circular patterns (11) with variousdiameters, as shown in FIG. 5. The patterns (11) could be elliptical,square, rectangular, other shapes including random shapes, orcrisscrossing as shown in FIG. 6. The hole spacing (12) within thepatterns (11) could vary to obtain different results of concentration ofchemicals from the dip (2). Any number of combinations could occur withthe object of providing a greater degree of concentration of thechemical than would be possible with a shield (1) with no holes (10).

Another embodiment of the shield (1) is related to the pouch embodimentabove and is shown in FIG. 7. The difference is that this embodiment isenvisioned to be a self-contained pouch (13) containing the shield (1),ends (8) to enclose the dip (2), a removable section (14), and aquantity of tobacco, such as dip (2). Ends (8) could be a part of theshield (1) or could be separate pieces of material. In someconfigurations, the self-contained pouch could be broken or torn inparts along for instance, a perforated line, then placed in the mouth.The self-contained pouch (13) may be opened to expose the enclosed dip(2) before or after insertion in the mouth (3), thus avoiding any wasteor mess. The self-contained pouch can be opened for example by thepacket pull tab (15). The manner of opening can also be made by atearaway string (16), as shown in FIG. 8. The manner of opening can alsobe made by a perforated line (17) that tears away, as shown in FIG. 9,and other methods to open the pouch, which generally would expose thetobacco. The manner of opening can even be made by a dissolvablematerial (18) that dissolves once the self-contained pouch is insertedinto the user's mouth, as shown in FIG. 10. The location of thedissolvable material could be in the top as shown in FIG. 10, on theends of the self-contained pouch, or in any other suitable place.

The present invention also involves a method as an improvement over thenormal manner of inserting the dip (2) into the mouth (3). The usercould remove the shield (1) as shown in FIG. 12a or in some mannerretrieve the shield (1). He may place it on a supporting surface, whichcould include another hand. He may secure a dip (2), generally betweentwo fingers from a can of smokeless tobacco, as shown in FIG. 3a,without needing the dip to leave the fingers. He may place the shield(1), for instance from another hand, below the fingers holding the dip(2) and in between other fingers and place the dip in the proximity ofthe shield, as shown in FIG. 7a. In the "proximity" may mean the diptouches the shield; it may mean that the dip and shield are held in onehand, or it may mean that another hand holds the dip close to the shieldso that together they may be inserted into the mouth, and so forth.Alternatively, the user may choose to place the dip on the shield placedon a surface or in another hand. The shield (1) may be slightly foldedto a curved position by fingers from the same hand holding the dip orfrom another hand to partially enclose the dip (2) and to prepare forinsertion into the mouth (3), as shown in FIG. 8a. The term "folded" mayinclude slightly curving the shield, completely wrapping the shieldaround the quantity of tobacco, or simply touching at least one face ofthe shield to the dip so that at least some of the quantity of smokelesstobacco temporarily adheres to the shield, for instance. The shield (1)and dip (2) may be inserted in the mouth (3), as shown in FIG. 9a. Theextra step or steps of using the shield (1) is important and providesthe protection needed and discussed herein. The dip (2) maysubstantially stay within the area of the shield (1) while in the mouth(3) for the duration of the use of the dip.

FIG. 10a shows a typical side view of a dip and a shield. The tobaccofibers, generally known as grains, are typically kept intact in theshield. The shield may wrap around the tobacco leaving seams for thesaliva to flow in and out of the tobacco. FIG. 10b and FIG. 10c show atypical end view and top view, respectively. A portion of the smokelesstobacco may be exposed to the saliva.

In the alternative embodiment of the pouch of FIG. 4, the pouch (1a) maybe handled between the fingers or placed in the hand, the dip (2) may bepulled from the can and placed in the pouch (1a), then the pouch (1a)may be inserted in the mouth (3).

In the embodiment of a self-contained pouch of FIGS. 7-10, theself-contained pouch (13) may be held, opened, then placed in the mouth,potentially without the need for a can and pulling a dip (2) of tobaccofrom the can. Alternatively, if the manner of opening is obtained by thedissolving of a portion of the packet, as shown in FIG. 10, then theentire self-contained pouch (13) may be placed in the mouth (3),yielding convenience and protection by the shield (1).

The system of the present invention also involves a container forholding the shields. The user's accessibility to the shield (1) isimportant to the successful protection gained by the shield (1). If theshield (1) is accessible, the user will be more inclined to use itregularly. Such accessibility can be achieved by the shield being in thevicinity of the smokeless tobacco when the user dips. The term"vicinity" is intented to mean that the shield may be located such thatready access can be gained by the user to the smokeless tobacco and theshield. If the user is inclined to use the shield, then the potentialprotection can occur. If the shields are not convenient, then the userwill not be inclined to use the shield and gain the potential fordisease protection. There are several ways in which this accessibilitycan be enhanced. These are not meant to be limiting but only suggestiveof the many ways one can envision such accessibility.

A typical can or container of smokeless tobacco is shown in FIG. 11. Itgenerally is circular, approximately 21/2 inches in diameter and 3/4inches high. One example of suitable containment and accessibility maybe to place the shield (1) into a container (19) of tobacco, as shown inthe cross-section of a container in FIG. 12. When the user opens a lid(20) on the container (19), the shields (1) could be laying on thetobacco (2a) in the container (19). The user could remove a shield (1),pull a dip (2) from the container (19), place the dip (2) on a shield(1), place the dip and shield in the mouth (3) (shown in FIG. 2), andreplace the remainder of the shields (1) in the tobacco container (19).

Another example of providing accessibility to the shields is shown inthe cross section of a container (19) in FIG. 13. By expanding acontainer lid (20), a chamber (21) can be made separate from the tobacco(2a). In the chamber (21), several shields can be placed. If the typicalnumber of dips from a can is 15-25, then an appropriate number ofshields could be placed inside the chamber (21).

The shields can be removed individually by allowing a chamber opening(22) in the container lid (20). The chamber opening (22) can be througha flip-top section (24) of the container lid (20) with a hinged orflexible portion (23), exposing the chamber (21) to retrieve a shield(1). This embodiment could just as easily be made into the containerbottom (26), instead of the container lid (20) by similar construction.It could also be made into the side of the container. This embodimentcan also be made as a separate container and separately marketed.

The chamber opening (22) could also be made through a removable tab (27)that can be peeled back, exposing the shields for removal, as shown inFIG. 14. Likewise, the opening (22) can be made through a screw-on top,a press-on top without threads, through a slit in the lid, or any numberof varieties of accessing the chamber (21), known to those in the art.

Another embodiment of a container could be a separate container ofshields. An example is shown in FIG. 15 and the cross section in FIG.16. A shield packet (28) could be marketed as a packet originally soldwith the container (19) or as a separate packet. By way of illustration,the shield packet (28) could contain two elements made of paper,plastic, or other suitable material, nominated an upper piece (29) and alower piece (30), joined to each other at one edge, forming an area tostore the shield (1). A user could pull a shield out of the shieldpacket (28) at the appropriate time. For convenience, an attachmentelement, such as a suitable adhesive, could be placed on the packetbottom (32) or other suitable place for attachment to the tobaccocontainer (19) or other convenient place.

A variation of FIG. 15 and FIG. 16 is FIG. 17 and its cross section,FIG. 18. A similar shield packet may be formed as in FIG. 15, but FIG.17 envisions a protective shield packet top (38). The packet top (38)may be helpful in maintaining the shield's sanitary condition. Thepacket top (38) may have a top tab (39) that can be inserted into a slot(37) of the lower piece (29) for securing the packet top (38). Anothervariation could be a resealable plastic bag to contain the shield orshields. A plastic bag might also provide a temporary repository for thetobacco juices generated from the dipping. Another embodiment of ashield packet is shown in FIGS. 18a and 18b. FIG. 18a shows a separatepacket similar to a paper match packet with the shield attached by, forexample, staples and containing a perforation to tear off the shieldfrom the packet. The packet could contain any suitable number ofshields.

Another embodiment for containing the shields (1) is shown in FIG. 19and FIG. 20. In this embodiment of the shield packet (28), a rotatabletop (33) may rotate about a pin (34) which may be secured to a shieldpacket bottom section (40) in a central position. The shield packetbottom section (40) may contain a chamber (21) for holding the shield(1) with a cutout (35) and a closed section (36). The rotatable top mayhave a corresponding cutout and closed section. Access to the shields(1) may be gained through the cutout (35) when the rotatable top (33) isaligned properly with respect to the cutout (35) as shown in FIG. 19. Ifthe rotatable top (33) is rotated with respect to the shield packetbottom section (40) toward the closed section (36) of the shield packet(28), the rotatable top (33) may cover the cutout (35) and the shields(1) are protected to some degree, as shown in FIG. 20.

Another embodiment of a container is shown in FIGS. 21 and 22. In thisvariation, shield packet bottom section (40) and the rotatable top (33)may be attached by the pin (34) in an offset position. By rotating therotatable top (33), the chamber (21) for shields (1) may be exposed,thereby gaining access to the shields.

Each of these shield holding embodiments could be made integral with thecontainer of tobacco, can be attached inside or outside the container onthe top, bottom, or sides, can be recessed in the container, can be madeseparate to attach to the container or other suitable containers throughadhesives or other attachment methods known to those in the art, orsimply be made separate to carry in addition to the container. Themarketplace and manufacturing concerns could dictate the appropriateembodiments.

The foregoing discussion and the claims that follow describe only thepreferred embodiments of the present invention. Particularly withrespect to the claims, it should be understood that a number of changesmay be made without departing from the essence of the present invention.In this regard, it is intended that such changes--to the extent thatthey substantially achieve the same results in substantially the sameway--would still fall within the scope of the present invention.

It simply is not practical to describe and claim all possible revisionsto the present invention which may be accomplished in general andspecifically regarding protecting oral tissues from smokeless tobaccothrough the use of the shield in the present invention. While these maybe added to explicitly include such details, the existing claims shouldbe construed to encompass such aspects.

To the extent the methods claimed in the present invention are notfurther discussed, they are natural outgrowths of the system orapparatus claims. Therefore, separate and further discussion of themethods are deemed unnecessary as they otherwise claim steps that areimplicit in the use and manufacture of the system or apparatus claims.Furthermore, the steps are organized in a logical fashion, however,other sequences can and do occur. Therefore, the method claims shouldnot be construed to include only the order of the sequence of stepspresented.

Furthermore, any references mentioned in the application for this patentas well as all references listed in any information disclosureoriginally filed with the application are hereby incorporated byreference in their entirety to the extent such may be deemed essentialto support the enablement of the invention(s). However, to the extentstatements might be considered inconsistent with the patenting ofthis/these invention(s) such statements are expressly not to beconsidered as made by the applicant(s).

I claim:
 1. A method of oral tissue protection for a user of smokelesstobacco comprising the steps of:a. obtaining a flexible shield; b.obtaining a quantity of smokeless tobacco; c. placing said quantity ofsmokeless tobacco in proximity to said shield; d. folding said shield;e. inserting said shield containing said smokeless tobacco into a mouthof said user; and f. positioning said shield to said user's preference.2. A method of oral tissue protection for a user of smokeless tobacco asdescribed in claim 1 wherein said step of obtaining said flexible shieldcomprises the step of extracting said shield from a shield container. 3.A method of oral tissue protection for a user of smokeless tobacco asdescribed in claim 2 wherein said step of extracting said shieldcomprises the step of extracting said shield from a shield containerattached to a smokeless tobacco container containing said smokelesstobacco.
 4. A protective system for oral tissue protection for a user ofsmokeless tobacco comprising:a quantity of smokeless tobacco; a foldableshield to hold said tobacco wherein said shield is designed to be foldedin a mouth of said user and at least partially enclose said tobacco; anda shield container comprising a chamber to hold said shield.
 5. Aprotective system for oral tissue protection for a user of smokelesstobacco as described in claim 4 further comprising a tobacco containerto hold said tobacco and wherein said shield container comprises anattaching element to attach said shield container to said tobaccocontainer.
 6. A protective system for oral tissue protection for a userof smokeless tobacco as described in claim 4 wherein said shieldcontainer comprises a flip-top section to open to remove said shield. 7.A protective system for oral tissue protection for a user of smokelesstobacco as described in claim 4 wherein said shield container comprisesa rotatable section to open to remove said shield.
 8. A protectivesystem for oral protection for a user of smokeless tobacco comprising:aflexible, universally conforming tobacco shield wherein said shield isdesigned to at least partially enclose a quantity of smokeless tobaccoand to universally conform inside a mouth of said user in an inter-oraland intra-oral manner without substantial oral topographical resistance;said shield being designed to at least partially form a preformed pouchand said preformed pouch is self contained to contain said quantity oftobacco; and wherein said pouch further comprises a removable section toopen said pouch.
 9. A protective system for oral tissue protection for auser of smokeless tobacco comprising as described in claim 8 whereinsaid removable section comprises a dissolvable material.
 10. Aprotective system for oral tissue protection for a user of smokelesstobacco comprising as described in claim 8 wherein said removablesection comprises a tearaway section.
 11. A protective system for oraltissue protection for a user of smokeless tobacco comprising asdescribed in claim 8 wherein said removable section comprises a tearawaystring.
 12. A protective system for oral tissue protection for a user ofsmokeless tobacco comprising:a. quantity of tobacco; b. a flexibleshield designed to at least partially enclose said quantity of tobacco;c. a tobacco container to contain said quantity of tobacco; and d. ashield container attached to said tobacco container to hold saidflexible shield.
 13. A protective system for oral tissue protection fora user of smokeless tobacco as described in claim 12 wherein said shieldcontainer comprises a chamber formed in a lid of said tobacco container.14. A protective system for oral tissue protection for a user ofsmokeless tobacco as described in claim 12 wherein said shield containercomprises a chamber integral to said tobacco container.
 15. A protectivesystem for oral tissue protection for a user of smokeless tobacco asdescribed in claim 12 wherein said shield container comprises a separatepacket.
 16. A protective system for oral tissue protection for a user ofsmokeless tobacco comprising:a quantity of smokeless tobacco; a foldableshield to hold said tobacco wherein said shield is designed to be foldedin a mouth of said user and at least partially enclose said tobacco;wherein said foldable shield is circular having a diameter of up to twoinches.